NCT04000490

Brief Summary

Chest pain is a very common reason for resorting to the call center. The etiologies are very varied, ranging from benign pathologies to some that may involve, in the short term, the vital prognosis such as Acute Coronary Syndrome (ACS). ACS is a partial or complete occlusion of a coronary artery that causes potentially irreversible myocardial pain unless prompt treatment is undertaken. ACS represents 120 000 cases per year in France and causes about 18 000 deaths. There is currently no support score for the assessment of chest pain. However, reducing the duration of management of ACS is essential in order to hope to reduce the associated morbidity and mortality. In 2016, SAMU45's team established a predictive ACS score for the assessement of chest pain in SAMU 45 (France) based on the prospective study of 1367 patients. Seven items significantly associated with this risk of ACS could be highlighted: age, sex, smoking, typicality (potentially constrictive chest pain radiating potentially to the shoulders and / or jaw) pain, inaugural character of pain (ie first episode of this type), presence of sweats and the physician's belief to be in the presence of an ACS. These seven variables make up the SCARE score. This had good internal discrimination (AUC at 0.81) and excellent calibration ("p" of Hosmer-Lemeshow at 0.74). This score makes it possible to stratify the risk of ACS, by using epidemiological elements but also the physician's belief, whose Negative Predictive Value (VPN) proved excellent. The objective of this new project is to confirm by an external validation via a multicentric study the robustness of this score and thus be able to consider its use in front of any chest pain regulated in France by a call center.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

June 7, 2019

Last Update Submit

August 31, 2020

Conditions

Keywords

Assessmentchest painACS predictive scorephysician's belief

Outcome Measures

Primary Outcomes (1)

  • SCARE score with evaluation of its calibration and its discrimination in a multicentric population

    Data will be collected during each patient's call for chest pain. Epidemilogical data (age, sex, weight, height) and clinical data will be collected, as well as the decision and the ressources committed by the regulating physician. For hospitalized patients, the diagnosis of acute coronary sydrom will be retained if patient meets the criteria defined by the European Society of Cardiology. For patients managed in ambulatory médicine, a telephone call to the patient will be made at one month in order to obtain the diagnosis.

    up to one month

Study Arms (1)

patient with a chest pain

adult patient with a chest pain calling for urgency center

Other: SCARE Score

Interventions

Predictive Score of acute coronary syndrome during the medical assessment of chest pain

patient with a chest pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient over the age of 18 calling call center for chest pain

You may qualify if:

  • Any patient over the age of 18 calling call center for chest pain
  • Posttraumatic chest pain,
  • Age under 18,
  • Patient not speaking French,
  • Patient refusing to participate in the study or refusing care
  • Patient not affiliated with social security,
  • Patients incarcerated in a penitentiary center,
  • Patients under guardianship, curatorship or safeguard of justice.

You may not qualify if:

  • \- Patient refusing to participate in the study or refusing care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Angers

Angers, 49100, France

Location

CHRU de Tours

Chambray-lès-Tours, 37170, France

Location

CHR d'Orléans

Orléans, 45067, France

Location

CHU poitiers

Poitiers, 86021, France

Location

Related Publications (3)

  • Faxon D, Lenfant C. Timing is everything: motivating patients to call 9-1-1 at onset of acute myocardial infarction. Circulation. 2001 Sep 11;104(11):1210-1. No abstract available.

    PMID: 11551867BACKGROUND
  • Mathew TP, Menown IB, McCarty D, Gracey H, Hill L, Adgey AA. Impact of pre-hospital care in patients with acute myocardial infarction compared with those first managed in-hospital. Eur Heart J. 2003 Jan;24(2):161-71. doi: 10.1016/s0195-668x(02)00521-3.

    PMID: 12573273BACKGROUND
  • Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.

    PMID: 22923432BACKGROUND

Related Links

MeSH Terms

Conditions

Chest PainAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Audrey GUERINEAU, MD

    CHR Orléans

    PRINCIPAL INVESTIGATOR
  • Paul Louis MARTIN, MD

    CHRU Tours - hopital trousseau

    PRINCIPAL INVESTIGATOR
  • Thomas MOUMNEH, MD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR
  • Jeremy GUENEZAN, MD

    CHU Poitiers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2019

First Posted

June 27, 2019

Study Start

October 1, 2019

Primary Completion

March 25, 2020

Study Completion

March 25, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations